Synergy Rx Recalls Tacrolimus Ointment Due to Sterility Concerns
Synergy Rx is recalling all lots of Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole 2% due to lack of assurance of sterility and CGMP deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a lack of assurance of sterility in a prescription topical medication, which aligns with the rubric criteria for Severe severity involving significant injury risks or Class II classifications with potential for serious harm.
Plain-English summary
Synergy Rx is recalling all lots of Tacrolimus 0.1% Ointment and Tacrolimus 0.1%/Ketoconazole 2% prescription ointments. The recall was initiated because of a lack of assurance of sterility and Current Good Manufacturing Practice (CGMP) deviations.
The affected products were distributed nationwide within the United States. The source text does not specify the number of units recalled or the specific dates of distribution.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synergy Rx, 4901 Morena Blvd #504-A San Diego, CA 92117 (855) 792-6676
- Manufacturer
- Synergy Rx
- Category
- Drug — Topical Prescription
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 81 recalled by Synergy Rx under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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